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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD UNKNOWN_MEDICAL - BELFAST_PRODUCT; AUTOMATED EXTERNAL DEFIBRILLATOR
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HEARTSINE TECHNOLOGIES LTD UNKNOWN_MEDICAL - BELFAST_PRODUCT; AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Catalog Number UNK_BEL
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Device (2588)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/04/2021
Event Type  malfunction  
Manufacturer Narrative
Heartsine continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
 
Event Description
Customer reported a discrepancy between ems and heartsine sam pad devices on two separate cases.Patients were involved in both cases however there is no adverse event reported in either case.
 
Manufacturer Narrative
The device was not returned to heartsine for investigation.No additional information will be forthcoming at this time; if the device is returned to the manufacturer the investigation will be reopened.H3 other text : device not returned for evaluation.
 
Event Description
Customer reported a discrepancy between ems and heartsine sam pad devices on two separate cases.Patients were involved in both cases however there is no adverse event reported in either case.
 
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Brand Name
UNKNOWN_MEDICAL - BELFAST_PRODUCT
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATOR
Manufacturer (Section D)
HEARTSINE TECHNOLOGIES LTD
203 airport road west
belfast BT3 9 ED
EI  BT3 9ED
MDR Report Key11875480
MDR Text Key255372812
Report Number3004123209-2021-00159
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 07/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberUNK_BEL
Was Device Available for Evaluation? No
Date Manufacturer Received07/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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